Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
AMITRIPTYLINE HYDROCHLORIDE (UNII: 26LUD4JO9K) (AMITRIPTYLINE - UNII:1806D8D52K), CHLORDIAZEPOXIDE (UNII: 6RZ6XEZ3CR) (CHLORDIAZEPOXIDE - UNII:6RZ6XEZ3CR)
Micro Labs Limited
ORAL
PRESCRIPTION DRUG
Chlordiazepoxide and amitriptyline hydrochloride tablets are indicated for the treatment of patients with moderate to severe depression associated with moderate to severe anxiety. The therapeutic response to chlordiazepoxide and amitriptyline hydrochloride tablet occurs earlier and with fewer treatment failures than when either amitriptyline or chlordiazepoxide is used alone. Symptoms likely to respond in the first week of treatment include: insomnia, feelings of guilt or worthlessness, agitation, psychic and somatic anxiety, suicidal ideation and anorexia. Chlordiazepoxide and amitriptyline hydrochloride tablet is contraindicated in patients with hypersensitivity to either benzodiazepines or tricyclic antidepressants. It should not be given concomitantly with a monoamine oxidase inhibitor. Hyperpyretic crises, severe convulsions and deaths have occurred in patients receiving a tricyclic antidepressant and a monoamine oxidase inhibitor simultaneously. When it is desired to replace a monoamine oxidase inhibito
The 5 mg/12.5 mg tablets are green, round, biconvex, film-coated tablets, debossed "CA 1" on one side and plain on the other side. They are available as follows: Bottles of 100 NDC 42571-302-01 Bottles of 500 NDC 42571-302-05 The 10 mg/25 mg tablets are white, round, biconvex, film-coated tablets, debossed "CA2"on one side, plain on the other side. They are available as follows:� Bottles of 100 NDC 42571-303-01 Bottles of 500 NDC 42571-303-05 Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature.] Store in a dry place. Keep in a tightly closed, child-resistant container and out of the light. Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873 Revised: 01/2023
Abbreviated New Drug Application
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE - CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE- CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET Micro Labs Limited ---------- MEDICATION GUIDE Chlordiazepoxide and Amitriptyline Hydrochloride (KLOR-dye-AZ-e-POX-ide/A-mi-TRIP-ti-leen hye-droe-klor-ide) Tablets, USP C-IV What is the most important information I should know about chlordiazepoxide and amitriptyline hydrochloride tablets? • Chlordiazepoxide and amitriptyline hydrochloride tablet is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death. Get emergency help right away if any of the following happens: • shallow or slowed breathing • breathing stops (which may lead to the heart stopping) • excessive sleepiness (sedation) Do not drive or operate heavy machinery until you know how taking chlordiazepoxide and amitriptyline hydrochloride tablets with opioids affects you. • Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including chlordiazepoxide and amitriptyline hydrochloride tablets, which can lead to overdose and serious side effects including coma and death. • Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including chlordiazepoxide and amitriptyline hydrochloride tablets. These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects. • You can develop an addiction even if you take chlordiazepoxide and amitriptyline hydrochloride tablets exactly as prescribed by your healthcare provider. • Take chlordiazepoxide and a Lue koko asiakirja
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE - CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE- CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET MICRO LABS LIMITED ---------- CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLETS, USP CIV WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; DEPENDENCE AND WITHDRAWAL REACTIONS; AND SUICIDAL THOUGHTS AND BEHAVIORS CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN PROFOUND SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH. RESERVE CONCOMITANT PRESCRIBING OF THESE DRUGS FOR PATIENTS FOR WHOM ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE. LIMIT DOSAGES AND DURATIONS TO THE MINIMUM REQUIRED. FOLLOW PATIENTS FOR SIGNS AND SYMPTOMS OF RESPIRATORY DEPRESSION AND SEDATION (SEE WARNINGS AND PRECAUTIONS). THE USE OF BENZODIAZEPINES, INCLUDING CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLETS, EXPOSES USERS TO RISKS OF ABUSE, MISUSE, AND ADDICTION, WHICH CAN LEAD TO OVERDOSE OR DEATH. ABUSE AND MISUSE OF BENZODIAZEPINES COMMONLY INVOLVE CONCOMITANT USE OF OTHER MEDICATIONS, ALCOHOL, AND/OR ILLICIT SUBSTANCES, WHICH IS ASSOCIATED WITH AN INCREASED FREQUENCY OF SERIOUS ADVERSE OUTCOMES. BEFORE PRESCRIBING CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLETS AND THROUGHOUT TREATMENT, ASSESS EACH PATIENT’S RISK FOR ABUSE, MISUSE, AND ADDICTION (SEE WARNINGS). THE CONTINUED USE OF BENZODIAZEPINES, INCLUDING CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLETS, MAY LEAD TO CLINICALLY SIGNIFICANT PHYSICAL DEPENDENCE. THE RISKS OF DEPENDENCE AND WITHDRAWAL INCREASE WITH LONGER TREATMENT DURATION AND HIGHER DAILY DOSE. ABRUPT DISCONTINUATION OR RAPID DOSAGE REDUCTION OF CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLETS AFTER CONTINUED USE MAY PRECIPITATE ACUTE WITHDRAWAL REACTIONS, WHICH CAN BE LIFE-THREATENING. TO REDUCE THE RISK OF WITHDRAWAL REACTIONS, USE A GRADUAL TAPER TO DISCONTINUE CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLETS OR REDUCE Lue koko asiakirja